Pharmacokinetics, pharmacodynamics, safety, and efficacy of crizanlizumab in patients with sickle cell disease: final results from the phase II SOLACE-adults study.

ABSTRACT:

Background

Crizanlizumab is a novel inhibitor of P-selectin, a key player in multicellular adhesion and inflammatory signaling, that leads to vaso-occlusion in sickle cell disease (SCD).

Objectives

The SOLACE-adults study evaluated the pharmacokinetics, pharmacodynamics (P-selectin inhibition), safety, and efficacy of crizanlizumab, with or without hydroxyurea/hydroxycarbamide, in patients with SCD.

Design

Phase II, single-arm, multicenter study.

Methods

Patients with SCD aged 16-70 years, with ⩾1 vaso-occlusive crisis (VOC) within 12 months before screening, received crizanlizumab 5.0 or 7.5 mg/kg intravenous infusion every 4 weeks; dose groups were enrolled sequentially.

Results

Of 57 patients enrolled, 45 received crizanlizumab 5.0 mg/kg and 12 receiv

SUBMITTER: Kanter J 

PROVIDER: S-EPMC11533247 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature